Key Responsibilities:
- Represent Bio DPD in the Product Presentation and Device Strategy Team (PPDST) and the CMC Team.
- Communicate development plans, risks, and mitigation plans to stakeholders and line management.
- Support scale-up and technology transfer to internal and external manufacturing sites.
- Lead design/execution of biologics drug product formulation and process development, characterization, and robustness studies.
- Initiate and/or support scientific initiatives to drive innovation and continuously enhance capabilities and business processes.
Qualifications:
- BS, MS, or PhD in Pharmaceutics/Pharmaceutical Sciences/Chemistry/Chemical Engineering or related fields.
- Principal Scientist I experience: 14+ (BS), 12+ (MS), or 6+ (PhD) years in relevant industry experience.
- Proven ability to solve critical scientific problems.
- Experience with biologics (proteins, conjugates, peptides, neurotoxins), parenteral synthetic molecules and/or genetic medicine (AAV, LNPs, cell therapy) drug product process development.
- Experience with sterile manufacturing unit operations (freeze-thaw, compounding, mixing, filtration and filling, lyophilization), characterization, scale-down models, simulation, scale-up, technology transfer, and batch record authoring.
- Experience leading drug product development as a functional lead in cross-functional teams.
Preferred Qualifications:
- Hands-on experience authoring regulatory filings for biologics/sterile parenterals.
- Understanding of relevant cGMP and regulatory guidance.
- Experience managing third-party sterile parenteral manufacturers.
- Experience with quality risk management and control strategies.
Benefits (if applicable):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k); eligible for short-term incentive programs.